Japanese Phase I of GSK1605786

Crohn's Disease Clinical Trial

Official title:

A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male Subject

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611805
• Other study ID #: 114472
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2012
• Last updated: June 13, 2017
• Start date: July 22, 2010
• Est. completion date: October 6, 2010

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an double-blind, single dose, four-period, crossover study in Japanese healthy male volunteers to assess the pharmacokinetics and safety/tolerability of single doses of GSK1605786A. Approximately 24 subjects will receive three treatments of 250, 500, and 1000mg GSK1605786 under fasted conditions or 500mg after food intake plus placebo in a dose ascending crossover design. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The pharmacokinetics and dose proportionality of GSK1605786 after single oral doses of GSK1605786 at the dose levels of 250mg, 500mg and 1000 mg under fasted conditions will be assessed. In addition, a comparison will be made between the pharmacokinetics of GSK1605786 under fed and fasted conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 6, 2010
• Est. primary completion date: October 6, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Japanese as

• Japanese defined as being born in Japan, having four ethnic Japanese grandparents, holding a Japanese passport or identity -Male between 20 and 55 years of age inclusive, at the time of signing the informed consent.

• Body weight =>50kg and BMI within the range 18.5 - 25 kg/m2 (inclusive).

Exclusion Criteria:

• Known coeliac disease or positive serologic testing for anti-tTG antibodies (required to screen for undiagnosed celiac disease)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• GSK1605786
Opaque Swedish orange body and cap.
• GSK1605786 Placebo
Opaque Swedish orange body and cap.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Randwick	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentration		up to 72h post dose
Secondary	Adverse envents		up to 72h post dose
Secondary	Vital signe		up to 72h post dose
Secondary	Clinical laboratory		up to 72h post dose
Secondary	12 lead ECG		up to 72h post dose

External Links

•   Results for study 114472 can be found on the GSK Clinical Study Register.